The disclosures herein related generally to a prosthesis and more particularly to an apparatus and method for stapling an annuloplasty band in-situ.
A conventional ring, disclosed in U.S. Pat. No. 4,055,861, completely surrounds the mitral or tricuspid valve annulus with the intent of supporting the entire annulus to prevent dilatation of the natural tissue. U.S. Pat. No. 4,144,046 discloses an early use of a flexible, partial ring or band. Subsequently, U.S. Pat. No. 4,164,046 disclosed a partial ring or band that reinforces the posterior portion of the mitral valve annulus but does not extend across the anterior portion of the annulus. It was believed by many that the fibrous anterior portion of the annulus is not subject to dilatation, in contrast to the muscular posterior portion of the annulus. Operative time can be reduced with the implantation of a partial band because fewer sutures are required to secure the band to the native valve annular tissue. Further, there is some risk of damaging the aortic valve leaflets when placing sutures in the anterior portion of the mitral valve annulus. A partial band limits this concern. Some surgeons do not use partial bands because in some cases, patients have experienced dilation of the fibrous anterior tissue. As a result, many surgeons continue to employ a complete ring.
Complete rings can be constructed at the operating table by the surgeon or purchased as a preconstructed product under the name Medtronic/Duran(tm) Annuloplasty Ring. Still, in many cases anterior reinforcement is not required, and therefore partial bands are used in some patients. Partial bands can be constructed at the operating table and are also commercially available under the name Baxter/Cosgrove(tm) Annuloplasty Ring.
There are several other known annuloplasty ring devices. U.S. Pat. No. 3,656,185 discloses a cardiac valvular prosthesis, e.g., for the mitral valve, consisting solely of an annular or part-annular member adapted to fit against the base of the cusps of a human heart valve and suture means for securing the member in place. The prosthesis cooperates with the natural valve cusps of the patient to form the valve. This device is a semi-rigid band with a shape that matches the correct anatomical shape of the native valve, allowing remodeling of the valve.
U.S. Pat. No. 4,042,979 discloses an adjustable valvuloplasty ring that comprises a C-shaped frame that is sized and shaped to extend about the circumference of the left atrioventricular orifice along the base of the anterior cusp of the mitral valve; an expandable sleeve connected to the frame that together therewith forms a closed annulus, the sleeve being adapted to extend about the remainder of the circumference of the orifice; and a drawstring running through the sleeve by which the sleeve may be contracted to constrict and remodel the orifice and secured in place to maintain such constriction. This ring is entirely flexible.
U.S. Pat. No. 4,164,046 discloses a valve prosthesis for mitral and tricuspid heart valves. The prosthesis is configured as an open band covered with a double velour fabric having a laterally projecting fabric appendage for simultaneously facilitating suturing the prosthesis in place and improving tissue infiltration.
U.S. Pat. No. 5,290,300 discloses an assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line. The assembly further includes a mechanism for releasably binding the suture guide to the surface of the holder and a detachable handle extendibly attached to the holder by means of a lanyard so that the handle can be detached to afford an unobstructed view of the surgical site, but cannot be removed from the surgical site until the holder has also been removed.
U.S. Pat. No. 5,716,370 discloses a heart valve is which can be replaced using minimally invasive methods which include a sutureless sewing cuff and a fastener delivery tool that holds the cuff against the patient""s tissue while delivering fasteners, two at a time in opposite directions, to attach the cuff to the tissue from the inside out. Drawstrings are operated from outside the patient""s body and cinch the sewing cuff to the valve body. The cuff is releasably mounted on the tool. The tool stores a plurality of fasteners thereon. Two rows of staggered fasteners are formed whereby fasteners are located continuously through-out the entire circumference of the cuff. A minimally invasive surgical method is disclosed, and a method and tool are disclosed for repairing abdominal aortic aneurysms in the minimally invasive manner.
The diagnosis of mitral and tricuspid regurgitation has been greatly simplified by advances in echocardiography. Initial diagnosis is possible with simple transthoracic echocardiography (TTE) that carries no risk for the patient. Detailed examination of the pathology is possible with transesophageal echocardiography that carries an extremely low risk for the patient. Despite the advances in diagnostic technology, current practice delays treatment of mitral and tricuspid valve pathology because the surgical morbidity creates risks that the patient and surgeon are reluctant to bear before the disease causes noticeable symptoms. By the time symptoms become noticeable, structural degradation of the valve is likely to have taken place, which might have been prevented by early intervention. This structural degradation of the valve often requires complex surgical maneuvers to correct the pathology or even replacement of the entire valve.
Therefore, what is needed is an apparatus and a method for reducing time and trauma associated with mitral valve repair.
One embodiment, accordingly, reduces time and trauma associated with mitral valve repair by replacing sutures with staples which are quickly applied through smaller, less traumatic incisions. To this end, apparatus is provided for attaching a prosthesis in-situ including an annuloplasty band, a positioning instrument for holding and positioning the band in a heart valve annulus, and a stapling device for attaching the band to the annulus simultaneously with the band being held in the annulus by the positioning instrument.
A principal advantage of this embodiment is that it reduces the time and trauma associated with mitral valve repair by replacing sutures with staples that can be applied more quickly by inserting the positioning instrument through a first small incision and by inserting the stapling device through a second small incision. Also, this embodiment allows more rapid placement of an annuloplasty band so that the time for patient exposure to cardiopulmonary bypass is substantially reduced.